Tuberculosis (TB) Test Serum/Plasma (Cassette)

• Instructions for use
• Pipette 
• Buffer
• Sterile lancet

Immunochromatographic assay

The (TB) Tuberculosis Test Serum/Plasma (Cassette) is a chromatographic immunoassay (CIA) for the direct qualitative detection of tuberculosis antibodies in human whole blood, serum, or plasma.

Test Procedure:

1. Bring the pouched test device to room temperature(15-30℃) before testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean, and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole blood to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops to the sample well. If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes. (Caution: The interpretation time is based on a room temperature range of 15-30°C. If your room temperature is significantly lower than 15℃, the interpreting time should be adequately increased to 30 minutes.)

• POSITIVE: Two pink lines appear in the result window. This indicates that the specimen contains a detectable amount of TB antibodies.
• NEGATIVE: Only one pink line appears in the test region of the result window. This indicates that there is no detectable TB antibody in the specimen.
• INVALID: No line appears in the control region regardless of the presence or absence of the line in the test region. (NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If the problem persists, contact your local distributor.)